Collagenases are enzymes that digest native collagen and are being evaluated for treatment of fibroproliferative disorders such as Dupuytren’s contracture and Peyronie’s disease. Clostridial collagenase is a bacterial collagenase derived from Clostridium histolyticum. Treatment of Dupuytren’s contracture consists of injection of collagenase into the cord followed by manipulation of the finger if contracture persists. Injection may be done up to 3 times at 4-week intervals.

Injection with clostridial collagenase is intended to provide a non-operative treatment option for fibroproliferative disorders. Fibrotic tissue disorders, characterized by excessive collagen deposits, can affect the musculoskeletal system causing pain and limitation of movement and reduction of joint range of motion. Dupuytren’s disease and adhesive capsulitis are such musculoskeletal disorders; Peyronie’s disease is another example.

The mechanisms that contribute to the pathology are poorly understood. In Dupuytren’s disease, collagen deposition results in nodules and cords in the palm and fingers resulting in pitting of the overlying cutis and flexion contractures. The standard of care for Dupuytren’s disease is surgery, most commonly open fasciectomy. Other surgical procedures are percutaneous fasciotomy and needle fasciotomy. Surgery is recommended in patients with functional impairment and metacarpophalangeal-joint contractures of 30 degrees or more. There is no effective pharmacotherapy. Adhesive capsulitis or “frozen shoulder” is treated with physiotherapy and mobilization in combination with analgesics or nonsteroidal anti-inflammatory drugs. Corticosteroid injection is used with caution. The prevalence of Dupuytren’s disease and adhesive capsulitis is estimated at 3-6% and 2-3%, respectively, in the general population and increases with advancing age. Both conditions are more common in patients with diabetes or thyroid disease. Dupuytren’s disease is more common in men and adhesive capsulitis more common in women.

Peyronie's disease is the development of abnormal scar tissue, or plaques, in the tunica albuginea layer of the penis causing distortion, curvature, and pain usually during erection. It occurs in 3-9% of men, most commonly between the ages of 45 and 60. In some cases, plaque does not cause severe pain or curvature, and the condition resolves on its own. In severe cases, erectile dysfunction can occur. The goal of treatment is to reduce pain and maintain sexual function. Treatments in early stages (before calcification) include vitamin E or para-aminobenzoate tablets (e.g., Potaba) although studies of oral therapies demonstrate inconsistent benefit. Intralesional injection therapy consisting of injection of interferon-alpha-2b or calcium channel-blockers (e.g., verapamil) is the current standard of therapy. Surgical procedures involve the excision (removal) of hardened tissue and skin graft, the removal or pinching (plication) of tissue opposite the plaque to reduce curvature (called the Nesbit procedure), a penile implant, or a combination of these.

In February 2010, the FDA approved Auxilium Pharmaceutical Inc.’s biologics license application for clostridial collagenase histolyticum (Xiaflex®) for treatment of adult patients with Dupuytren’s contracture with a palpable cord. The FDA labeling for Xiaflex states that up to 3 injections at 4-week intervals may be given into a palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint.

Injectable clostridial collagenase for the treatment of Dupuytren’s contracture in adult patients with a palpable cord may be considered medically necessary, for up to three injections at intervals of at least thirty days. Inject up to two cords in the same hand at a treatment visit. If a patient has other cords with contractures, inject those cords at another treatment visit. Approximately 24-72 hours following an injection, a finger extension procedure can be performed if a contracture persists.

Injectable clostridial collagenase is considered investigational for all other indications including, but not limited to Peyronie’s disease and adhesive capsulitis.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

12/09/2011: Policy statement revised to state that effective 12/09/2011, injectable clostridial collagenase for the treatment of Dupuytren’s contracture in adult patients with a palpable cord may be considered medically necessary, for up to three injections at intervals of at least thirty days. Prior Authorization is required. Added HCPCS code J0775 to the Code Reference section and deleted the unlisted code J3590. Added ICD-9 code 728.6 to the Covered Codes table.

01/17/2012: Added 20527 to the Covered Codes table.

11/28/2012: Policy reviewed; no changes.

12/13/2013: Policy reviewed; no changes.

11/06/2014: Medically necessary policy statement updated to remove "Effective 12/09/2011" and add: Inject up to two cords in the same hand at a treatment visit. If a patient has other cords with contractures, inject those cords at another treatment visit. Approximately 24-72 hours following an injection, a finger extension procedure can be performed if a contracture persists.